A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer

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NCT07581184 · readout ≤ 499 d

Sponsored by Aktis Oncology, Inc. (industry) · AKTS — their whole pipeline →.

Phase

Phase 1

Status

Recruiting

Study type

Interventional

Design

Na · None · Treatment

Enrollment

138estimated

Sites

Country

United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

Jul 2026

estimated

When the study began enrolling

Primary completion

Dec 2027

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

Jun 2032

estimated

The whole study's end, after follow-up

First posted

2026-05-12

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-07-14

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

Castration Resistant Metastatic Prostate Cancer
Prostate Cancer
mCRPC (Metastatic Castration-resistant Prostate Cancer)
mCRPC
B7H3

Interventions

Drug: [225Ac]Ac-AKY-2519 (therapeutic)
Drug: [64Cu]Cu-AKY-2519 (imaging)

Primary outcomes

what the primary-completion date above is the date OF

Occurrence of adverse events by severity and occurrence of serious adverse events (SAEs) in participants who received [225Ac]Ac-AKY-2519

measured Up to 30 days following last administration of [225Ac]Ac-AKY-2519

Occurrence of dose-limiting toxicity (DLT) in mCRPC participants with and without prior 177Lu-PSMA-617 exposure

measured From first administration of [225Ac]Ac-AKY-2519 to the end of Cycle 1 (each cycle is 28 days)

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